PMID- 24962242
OWN - NLM
STAT- MEDLINE
DCOM- 20140929
LR  - 20180531
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 55
IP  - 8
DP  - 2014 Aug
TI  - Adjunctive use of controlled-release pregabalin in adults with 
      treatment-resistant partial seizures: a double-blind, randomized, 
      placebo-controlled trial.
PG  - 1220-8
LID - 10.1111/epi.12690 [doi]
AB  - OBJECTIVES: To assess the efficacy and tolerability of add-on pregabalin 
      controlled-release formulation (PGB-CR) (doses of 165 or 330 mg/day) in patients 
      with partial-onset seizures (POS). METHODS: This was a randomized, double-blind 
      (DB), parallel-group study of PGB-CR once-daily as adjunctive treatment in adults 
      with treatment-resistant partial seizures. After an 8-week baseline period, 
      eligible patients were randomized (1:1:1) to placebo, PGB-CR 165 mg, or PGB-CR 
      330 mg for 14 weeks, including a 2-week dose escalation. Primary endpoint was the 
      loge -transformed 28-day seizure rate for all POS with observable component 
      during the full 14-week double-blind treatment phase. Secondary endpoints 
      included the 50% responder rate and percent change from baseline in 28-day POS 
      rate. RESULTS: Three hundred twenty-three patients were randomized and received 
      treatment; placebo (n = 110), PGB-CR 330 mg (n = 100), PGB-CR 165 mg (n = 113); 
      and 287 (88.9%) completed the trial. The primary efficacy analysis result, 
      expressed as percent reduction from placebo, was 13.1% and 1.0% for PGB-CR 330 mg 
      and PGB-CR 165 mg, respectively, and was not statistically significant (p = 
      0.091, 0.908). The proportion of 50% responders was similar for placebo (35.8%) 
      and 165 mg PGB-CR (37.8%) and nominally higher for 330 mg PGB-CR (45.9%, p = 
      0.125 compared to placebo). The LS mean estimates of the percent change from 
      baseline for placebo (-5.7%) was nominally smaller than 165 mg PGB-CR (-15.0%, p 
      = 0.540) and 330 mg PGB-CR (-31.5%, p = 0.079); however, the median percent 
      changes from baseline were not as well differentiated (placebo, -35.4%; 165 mg 
      PGB-CR, -38.0%; 330 mg PGB-CR -43.4%). Rates of adverse events (AEs) were low for 
      placebo and study drug; the most frequent reported AEs were dizziness, 
      somnolence, and fatigue, consistent with the immediate-release formulation. 
      SIGNIFICANCE: Results from this trial did not demonstrate that PGB-CR is 
      effective in reducing seizure frequency below that of placebo. Both doses of 
      PGB-CR were shown to be safe and well-tolerated.
CI  - Wiley Periodicals, Inc. (c) 2014 International League Against Epilepsy.
FAU - French, Jacqueline
AU  - French J
AD  - NYU Comprehensive Epilepsy Center, New York, New York, U.S.A.
FAU - Brandt, Christian
AU  - Brandt C
FAU - Friedman, Daniel
AU  - Friedman D
FAU - Biton, Victor
AU  - Biton V
FAU - Knapp, Lloyd
AU  - Knapp L
FAU - Pitman, Verne
AU  - Pitman V
FAU - Chew, Marci
AU  - Chew M
FAU - Dubrava, Sarah
AU  - Dubrava S
FAU - Posner, Holly B
AU  - Posner HB
LA  - eng
SI  - ClinicalTrials.gov/NCT01262677
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140624
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Delayed-Action Preparations)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticonvulsants/*administration & dosage
MH  - Delayed-Action Preparations/administration & dosage
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/*diagnosis/*drug therapy/physiopathology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pregabalin
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/administration & dosage/*analogs & derivatives
OTO - NOTNLM
OT  - Clinical
OT  - Controlled-release
OT  - Epilepsy
OT  - Extended-release
OT  - Lyrica
OT  - Pregabalin
EDAT- 2014/06/26 06:00
MHDA- 2014/09/30 06:00
CRDT- 2014/06/26 06:00
PHST- 2014/05/12 00:00 [accepted]
PHST- 2014/06/26 06:00 [entrez]
PHST- 2014/06/26 06:00 [pubmed]
PHST- 2014/09/30 06:00 [medline]
AID - 10.1111/epi.12690 [doi]
PST - ppublish
SO  - Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.